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December 9, 1998

The Changing Treatment Paradigm for Acute Otitis Media—Reply

Author Affiliations

Margaret A.WinkerMD, Senior EditorIndividualAuthorPhil B.FontanarosaMD, Senior EditorIndividualAuthor

JAMA. 1998;280(22):1903-1904. doi:10-1001/pubs.JAMA-ISSN-0098-7484-280-22-jac80017

In Reply.—We agree with Dr Cantekin's call for a large, multicenter, randomized controlled trial to address the question of whether any antibiotic is indicated for treatment of children with AOM. If the primary outcome of treatment is the status of the eardrum and hearing, the evidence currently available makes it predictable that a randomized controlled trial comparing antibiotic with placebo will show similar results for each group, at least at 3 months and probably at 1 month. However, we do not believe that the evidence is sufficient to advocate that physicians in the United States "cease prescribing antibiotics for AOM." The meta-analysis by Del Mar et al1 was well done, but it was not completely negative. There was less pain at 2 to 7 days in patients treated with antibiotics, not an inconsequential issue for children and parents. We do not have studies that look at the safety and efficacy of other methods of pain control in children with AOM. To ascertain whether children who do not receive antibiotics initially are at increased risk of rare complications, such as mastoiditis or meningitis, may not be discernible in a randomized controlled trial because the sample size would need to be quite large. Surveillance with use of databases in jurisdictions in which a lower rate of antibiotic usage is documented would be important to ensure that this is a safe approach. In the Netherlands, where antibiotics are prescribed for 30% of AOM cases, no increase in such complications has been documented.2

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